What the label lists and what reports show
Sugammadex side effects
Sugammadex's FDA label: “Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache.” FAERS holds 3,095 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is anaphylactic reaction (381 reports).
- Generic listed
Check it at the source: the sugammadex FDA label on DailyMed (effective March 13, 2026, Merck Sharp & Dohme LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache.
Table 2: Percent of Subject Exposures in Pooled Phase 1 to 3 Studies with Adverse Reactions Incidence ≥2%
| Body System Preferred Term | 2 mg/kg (N=895) n (%) | 4 mg/kg (N=1921) n (%) | 16 mg/kg (N=98) n (%) | (N=544) n (%) |
|---|---|---|---|---|
| Incision site pain | 58 (6) | 106 (6) | 4 (4) | 6 (1) |
| Procedural complication | 13 (1) | 27 (1) | 8 (8) | 3 (1) |
| Airway complication of anesthesia | 11 (1) | 13 (1) | 9 (9) | 0 |
| Anesthetic complication | 8 (1) | 14 (1) | 9 (9) | 1 (<1) |
| Wound hemorrhage | 5 (1) | 38 (2) | 0 | 8 (1) |
| Recurrence of neuromuscular blockade | 0 | 1 (<1) | 2 (2) | 0 |
| Nausea Combinations of preferred terms are as follows: Nausea includes preferred terms… | 208 (23) | 503 (26) | 23 (23) | 127 (23) |
| Vomiting | 98 (11) | 236 (12) | 15 (15) | 57 (10) |
| Abdominal pain | 48 (5) | 68 (4) | 6 (6) | 17 (3) |
| Flatulence | 17 (2) | 51 (3) | 1 (1) | 10 (2) |
| Dry mouth | 9 (1) | 5 (<1) | 2 (2) | 0 |
| Pain | 434 (48) | 993 (52) | 35 (36) | 207 (38) |
| Pyrexia | 77 (9) | 109 (6) | 5 (5) | 17 (3) |
| Chills | 30 (3) | 61 (3) | 7 (7) | 27 (5) |
| Headache | 61 (7) | 99 (5) | 10 (10) | 42 (8) |
| Dizziness | 44 (5) | 67 (3) | 6 (6) | 13 (2) |
| Hypoesthesia | 12 (1) | 24 (1) | 3 (3) | 9 (2) |
| Oropharyngeal pain | 42 (5) | 66 (3) | 5 (5) | 27 (5) |
| Cough | 13 (1) | 49 (3) | 8 (8) | 11 (2) |
| Pain in extremity | 13 (1) | 35 (2) | 6 (6) | 15 (3) |
| Musculoskeletal pain | 16 (2) | 33 (2) | 1 (1) | 6 (1) |
| Myalgia | 5 (1) | 17 (1) | 2 (2) | 3 (1) |
| Insomnia | 20 (2) | 103 (5) | 5 (5) | 22 (4) |
| Anxiety | 14 (2) | 19 (1) | 3 (3) | 1 (<1) |
| Restlessness | 3 (<1) | 17 (1) | 2 (2) | 2 (<1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: Anaphylaxis and Hypersensitivity [see Contraindications (4), Warnings and Precautions (5.1) ] Marked Bradycardia [see Warnings and Precautions (5.2) ] Most common adverse reactions (reported in ≥10% of adult patients at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate): vomiting, pain, nausea, hypotension, and headache. ( 6.1 ) Most common adverse reactions (reported in ≥10% of pediatric patients 2 to <17 years of age at BRIDION doses of 2 or 4 mg/kg) were pain, vomiting, and nausea. ( 6.1 ) Most common adverse reaction (reported in ≥10% of pediatric patients from birth to <2 years of age at BRIDION doses of 2 or 4 mg/kg) was procedural pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients The data described below reflect 2914 subjects exposed to 2, 4, or 16 mg/kg BRIDION and 544 to placebo in pooled Phase 1-3 studies. …
Source: FDA drug label, Merck Sharp & Dohme LLC, effective March 13, 2026 (SPL set 5171d883-fe8f-482c-97ab-40b00975b64a), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,095 reports list sugammadex among the medicines taken, each a report of something that happened, not proof the medicine caused it; 124 are coded as a death and 1,048 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sugammadex: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions